Trial Information

Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL).

Given that:

- rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated
with a high OR rate, superior PFS and OS as compared to fludarabine and
cyclophosphamide regimen;

- a direct relationship between the dose of rituximab and the response rate has been
reported;

- ofatumumab, as single agent, proved activity in CLL patients with refractory disease;

- ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been
associated with a high complete response (CR) rate;

- the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study
drugs (FC) and increase the infection rate; a schedule combining FC with an increased
dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be
associated with an improvement in the CR rate. The purpose of this study is to
determine whether we could improve the CR rate of the golden standard treatment for fit
patients with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined
with an increased dose of the monoclonal antibody ofatumumab, given every other week
(FCO2) associated with a primary prophylaxis of granulocytopenia.

- For male and female subjects of childbearing potential, agreement to use effective
contraception.

- Signed written informed const according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease and/or laboratory abnormality which in the opinion of the
investigator may represent a risk for the patient and/or that would prevent the
subject from signing the informed consent form.

- Pregnant or lactating females.

- Known positive serology for HIV.

- Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and
HBV-DNA.

- Treatment with any known non-marketed drug substance or experimental therapy within 5
terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently
participating in any other interventional clinical study

- Other past or current malignancy. Subjects who have been free of malignancy for at
least 5 years, or have a history of completely resected non-melanoma skin cancer, or
successfully treated in situ carcinoma are eligible.

Completion Date:

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